TERRASIL ANTI-FUNGAL TREATMENT  MAX- clotrimazole ointment 
Aidance Skincare & Topical Solutions, LLC

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Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Warnings

For external use only. Do not useon children under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product.

Inactive Ingredients

beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, witch hazel, zinc oxide

Other information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Product label

image descriptionimage description

TERRASIL ANTI-FUNGAL TREATMENT   MAX
clotrimazole ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCONUT OIL (UNII: Q9L0O73W7L)  
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
PALM OIL (UNII: 5QUO05548Z)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SAGE OIL (UNII: U27K0H1H2O)  
SILVER STEARATE (UNII: 4H6PCL92ZN)  
TEA TREE OIL (UNII: VIF565UC2G)  
WITCH HAZEL (UNII: 101I4J0U34)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-106-1414 g in 1 JAR; Type 0: Not a Combination Product09/07/201205/22/2017
2NDC:24909-106-4444 g in 1 JAR; Type 0: Not a Combination Product09/07/201205/22/2017
3NDC:24909-106-1514 g in 1 TUBE; Type 0: Not a Combination Product10/02/2023
4NDC:24909-106-5050 g in 1 TUBE; Type 0: Not a Combination Product10/02/2023
5NDC:24909-106-20200 g in 1 JAR; Type 0: Not a Combination Product10/02/2023
6NDC:24909-106-1010 g in 1 TUBE; Type 0: Not a Combination Product10/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00509/07/2012
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-106)

Revised: 11/2023
Document Id: 092f9970-a5df-3896-e063-6294a90a8aec
Set id: db356cc8-f473-4eb2-b8d8-72606fca9dc0
Version: 10
Effective Time: 20231102
 
Aidance Skincare & Topical Solutions, LLC